Department of Health and Human Services June 20, 2013 – Federal Register Recent Federal Regulation Documents

The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Adolescent Development and Support (DADS) announces the award of single-source expansion supplement grants to eight PREIS grantees for the purpose of expanding program participation and/or sites to support the increase of data necessary to determine the level of program effectiveness. In FY 2010, FYSB awarded 13 cooperative agreement grants under Funding Opportunity Announcement (FOA) number: OPHS/OAH/TPP PREP Tier 2-2010. Under this FOA, a total of $9.7 million was made available on a competitive basis to implement and test innovative strategies. Single-source program expansion supplement awards are made to the following PREIS grantees:

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990-0275 scheduled to expire on October 31, 2013. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``ANDAs: Stability Testing of Drug Substances and Products.'' FDA is recommending generic drug manufacturers follow the stability testing recommendations in the International Conference on Harmonisation (ICH) guidances Q1A (R2) through Q1E. The use of these ICH recommendations will standardize FDA's stability testing policies, which will help make the abbreviated new drug application (ANDA) review process more efficient.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to Mitchell Woods Pharmaceuticals, LLC, of an exclusive commercialization license to practice the inventions embodied in the following U.S. Patent Applications (and all continuing applications and foreign counterparts): Serial No. 61/651,961, filed May 25, 2012, entitled, ``Methods of Regulating Cannabinoid Receptor Activity-related Disorders and Diseases'' [HHS Reference E-139-2012/0-US-1]; Serial No. 61/ 789,629, filed March 15, 2013, entitled, ``Methods of Regulating Cannabinoid Receptor Activity-related Disorders and Diseases'' [HHS Reference E-139-2012/1-US-1]; Serial No. 61/312,642, filed March 10, 2010, entitled, ``The Use of Fenoterol and Fenoterol Analogues in the Treatment of Glioblastomas and Astrocytomas'' [HHS Reference E-013- 2010/0-US-01]; Serial No. 60/837,161, filed August 10, 2006, entitled, ``Preparation of R,R-Fenoterol and R,R-Fenoterol Analogues and Their Use in Congestive Heart Failure'' [HHS Reference E-205-2006/0-US-1]; and Serial No. 60/927,825, filed May 3, 2007, entitled ``Preparation of R,R-Fenoterol and R,R-Fenoterol Analogues and Their Use in Congestive Heart Failure'' [HHS Reference E-205-2006/1-US-1]. The patent rights in these inventions have been assigned or exclusively licensed to the Government of the United States of America. The prospective exclusive commercialization license territory may be worldwide, and the scope may be limited to the following two fields of use: